Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3
研究概览
简要总结
This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
详细描述
The primary objective of this phase IV, randomized, placebo controlled clinical trial is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute bacterial rhinosinusitis. The secondary objective is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on functional status, symptoms, disease recurrence, satisfaction with treatment, and direct costs of treatment in adults with clinically diagnosed acute bacterial rhinosinusitis. The tertiary objective is to identify prognostic indicators for clinical improvement with antibiotic treatment in adults with clinically diagnosed acute bacterial rhinosinusitis. Two hundred adult subjects, 18 to 70 years old, who meet the recommended criteria for acute bacterial rhinosinusitis, will be enrolled from 8 practice sites. Subjects will be randomized to receive a 10-day course of either amoxicillin or placebo. In addition, all subjects will receive an analgesic, an oral decongestant, a nasal saline spray, and an antitussive agent. Subject outcomes will be assessed by telephone interview at 0, 3, 7, 10, and 28 days. The primary outcome is the disease-specific quality of life at Day 3 measured with the SNOT-16, a validated evaluative instrument. Secondary outcomes include change in functional status and symptoms, disease recurrence, satisfaction with care and the direct costs of treatment. Tertiary outcome measures include possible subject and disease-related factors that predict clinical improvement with antibiotic treatment at Day 3 for use in future studies to aid clinical decision-making.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be male or female, and between the ages of 18 and 70 years old.
- •The subject must have symptoms of acute bacterial rhinosinusitis.
- •The subject must be attending a participating primary care practice in the community.
- •The subject must have symptoms of acute bacterial rhinosinusitis self-assessed as moderate, severe, or very severe.
- •The subject must have access to a phone.
排除标准
- •The subject is less than 18 years old or more than 70 years old.
- •The subject has very mild or mild symptom severity assessed by self report.
- •The subject has an allergy to penicillin or amoxicillin.
- •The subject has received antibiotic therapy within the past 4 weeks (including chronic treatment for acne and low dose prophylactic treatment).
- •The subject has complications of sinusitis (facial edema, cellulitis, or orbital, meningeal or cerebral signs).
- •The subject is thought to require intravenous antibiotics or hospital admission.
- •The subject is pregnant. (This will be assessed by self-report. A pregnancy test will not be required).
- •The subject has a comorbidity that may impair their immune response (such as immunodeficiency disease, uncontrolled cancer, or chemotherapy or radiation treatment).
- •The subject has cystic fibrosis.
- •The subject has Type I diabetes or is taking insulin to treat diabetes.
- •The subject had prior sinus surgery.
- •The subject requires an antibiotic for a concurrent condition such as an ear infection.
- •The subject is not able to complete the study protocol because of language barriers, lack of telephone access, or other issues.
- •Any other condition that the provider feels may interfere with the study.
研究组 & 干预措施
Intervention Arm
Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments
干预措施: Acetaminophen (Drug)
Intervention Arm
Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments
干预措施: Amoxicillin (Drug)
Intervention Arm
Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments
干预措施: Dextromethorphan hydrobromide with guaifenesin (Drug)
Intervention Arm
Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments
干预措施: Guaifenesin (Drug)
Intervention Arm
Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments
干预措施: Pseudoephedrine Sustained Action (Drug)
Intervention Arm
Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments
干预措施: Saline spray (0.65%) (Drug)
Symptomatic treatments only
Placebo for 10 days in addition to symptomatic treatments
干预措施: Acetaminophen (Drug)
Symptomatic treatments only
Placebo for 10 days in addition to symptomatic treatments
干预措施: Dextromethorphan hydrobromide with guaifenesin (Drug)
Symptomatic treatments only
Placebo for 10 days in addition to symptomatic treatments
干预措施: Guaifenesin (Drug)
Symptomatic treatments only
Placebo for 10 days in addition to symptomatic treatments
干预措施: Pseudoephedrine Sustained Action (Drug)
Symptomatic treatments only
Placebo for 10 days in addition to symptomatic treatments
干预措施: Saline spray (0.65%) (Drug)
结局指标
主要结局
SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3
时间窗: 4 days
The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact).
次要结局
未报告次要终点
研究者
Jane Garbutt, MD
Associate Professor
Washington University School of Medicine